In many in-vitro diagnostic (IVD) testing procedures there is a need to prepare reagents by reconstituting and/or mixing multiple necessary components, some in a liquid and others in a powder format. Currently, reconstituting or mixing reagents for an IVD procedure is achieved by manual operation. For instance, in a diagnostic testing lab, before using the reagents for sample testing, typically body fluids such as whole blood, plasma, serum, urine, cerebrospinal fluid and so on, medical workers collect different reagent components from separate vials/bottles, use a pipette to pipette diluents with a certain volume to a vial of powder reagents or to a vial with concentrated liquid reagents, wait for certain time for reconstitution, and finally mix the reagents manually by shaking, stirring, or rotating, for example. This manual process reduces the speed in which a diagnostic test takes place, increases the risk of human error and operator contamination with potentially toxic chemicals, and raises the cost of packaging.
Dual-chamber syringe systems developed for drug preparation, provide a solution for mixing drug components such as a lyophilized active component and a diluent like water or saline, by packaging two drug components in a single device such as a dual barrel syringe thereby partially automating the drug reconstitution process. However, the syringe device is disadvantaged by a complex manufacturing and assembly process. The cost of the manufacturing and assembly is not a factor for drug manufacturers in view of the price of the drug to the consumer. But such devices are not practical for IVD test applications, where the packaging cost for IVD test applications must be controlled to be very low because of the low cost of the test to the consumer.
In addition, the volume inside a syringe is relatively low, compared to reagent volume in IVD testing, potentially a liter or more, such as a test run by an automated clinical analyzer, to achieve effective reconstitution and mixing. In addition to the need to reconstitute reagents for IVD applications, the contents of current reagent vials used in diagnostic instruments such as automated clinical analyzers, are subject to evaporation when on-board the instrument. Such evaporation compromises reagent stability, alters reagent concentration, and is generally wasteful of reagents, increasing the cost for the user.
In order to improve the current reagent preparation process and usage efficiency for IVD applications in a clinical analyzer, a reagent packaging solution with multi-components storage, automated reconstitution and mixing, and evaporation prevention is needed.